Ulcerative ColitisPhase 2NCT01839214
A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With Ulcerative Colitis
A Phase 2 study testing VB-201 160mg in people with Ulcerative Colitis, run by Vascular Biogenics Ltd. operating as VBL Therapeutics at 3 sites in 3 countries.
Trial summary
This study will examine the safety and efficacy in subjects with mild to moderate ulcerative colitis, as measured by Modified Mayo Score, Modified Baron Score, IBDQ, calprotectin and other assessments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- VB-201 160mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jan 2013to Nov 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, ≥18 years of age, who has a diagnosis of active UC for at least 6 months prior to screening
- A rectal/colonic biopsy obtained previously and consistent with a diagnosis of UC
- Endoscopy (flexible sigmoidoscopy unless surveillance colonoscopy is clinically indicated) confirming diagnosis of UC within 2 weeks prior to randomization
- Endoscopy (flexible sigmoidoscopy unless surveillance colonoscopy is clinically indicated) confirming diagnosis of UC within 2 weeks prior to randomization
- Active UC despite previous treatment with at least one 5-ASA compound at a dose of ≥2000 mg/day for at least 4 weeks or documented intolerance to such therapy
Who cannot join
- Diagnosis of indeterminate colitis, Crohn's disease, or clinical findings suggestive of Crohn's disease (fistula or granulomas on biopsy) or microscopic colitis (collagenous colitis or lymphocytic colitis)
- Subject whose symptoms are likely caused by factors other than inflammatory UC, including infection or irritable bowel syndrome (IBS)
- History of dysplasia on colonic biopsy
- Subject with ≥ 8 year history of pancolitis or ≥ 15 year history of left sided colitis unless a colonoscopy with surveillance biopsies to screen for colon cancer has been performed within the past year
- Subject ≥ 50 years of age who has not had a colonoscopy to screen for colorectal polyps and colon cancer within the past 5 years
- Subject who has had any prior surgical resection of any part of the colon excluding the appendix
Show all 11Show fewer
- Previous treatment with any biologic product including investigational biologic products within 1 year prior to baseline visit
- The subject is taking Systemic corticosteroids, Azathioprine/6-mercaptopurine/methotrexate, immunosuppressants, Oral 5-ASA compounds unless they have been on a stable dose of sufficient duration prior to Baseline. If recently discontinued the subject must have had a wash-out periods of sufficient duration prior to Baseline
- Rectally administered corticosteroids or 5-ASA, antibiotics for the treatment of UC and probiotics within 14 days of the Baseline Visit and throughout the study
- The subject has with a stool culture positive for pathogenic ova or parasites, enteric pathogens or Clostridium difficile toxin at the Screening Visit
- Presence of, or history of cancer, with the exception of skin cancer
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects With Mild to Moderate Ulcerative Colitis
This study will examine the safety and efficacy in subjects with mild to moderate ulcerative colitis, as measured by Modified Mayo Score, Modified Baron Score, IBDQ, calprotectin and other assessments.
- Conditions
- Ulcerative Colitis
- Being tested
- VB-201 160mg, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VB-201 160mgDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| VB-201 160mg | Experimental | Subjects will received 80mg twice daily for 24 weeks. Receives: Drug: VB-201 160mg |
| Placebo with crossover to VB-201 160mg | Placebo comparator | Subjects on placebo will crossover to VB-201 160 at week 12. Receives: Drug: VB-201 160mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Mayo Score indicating remission
The proportion of subjects in remission at Weeks 12 and 24 in the VB-201 160mg (80 mg BID) treatment group compared to placebo group.
Measured: Week 12 and Week 24
Secondary outcomes (1)
Modified Mayo Score indicating response
The proportion of subjects responding at Weeks 12 and 24 in the VB-201 160mg (80 mg BID) treatment group compared to placebo group.
Measured: Week 12 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vascular Biogenics Ltd. operating as VBL Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839214
- Sponsor's protocol ID
- VB-201-064
- Status last verified
- Mar 2015
- First submitted
- 21 Apr 2013
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects With Mild to Moderate Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT01839214
- Acronym / sponsor ID
- VB-201-064
- Conditions
- Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Vascular Biogenics Ltd. operating as VBL TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 24 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the safety and efficacy in subjects with mild to moderate ulcerative colitis, as measured by Modified Mayo Score, Modified Baron Score, IBDQ, calprotectin and other assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VB-201 160mg | Experimental | Drug: VB-201 160mgSubjects will received 80mg twice daily for 24 weeks. |
| Placebo with crossover to VB-201 160mg | Placebo comparator | Drug: VB-201 160mg, Drug: PlaceboSubjects on placebo will crossover to VB-201 160 at week 12. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, ≥18 years of age, who has a diagnosis of active UC for at least 6 months prior to screening
- A rectal/colonic biopsy obtained previously and consistent with a diagnosis of UC
- Endoscopy (flexible sigmoidoscopy unless surveillance colonoscopy is clinically indicated) confirming diagnosis of UC within 2 weeks prior to randomization
- Endoscopy (flexible sigmoidoscopy unless surveillance colonoscopy is clinically indicated) confirming diagnosis of UC within 2 weeks prior to randomization
- Active UC despite previous treatment with at least one 5-ASA compound at a dose of ≥2000 mg/day for at least 4 weeks or documented intolerance to such therapy
Key exclusion criteria (11 listed)
- Diagnosis of indeterminate colitis, Crohn's disease, or clinical findings suggestive of Crohn's disease (fistula or granulomas on biopsy) or microscopic colitis (collagenous colitis or lymphocytic colitis)
- Subject whose symptoms are likely caused by factors other than inflammatory UC, including infection or irritable bowel syndrome (IBS)
- History of dysplasia on colonic biopsy
- Subject with ≥ 8 year history of pancolitis or ≥ 15 year history of left sided colitis unless a colonoscopy with surveillance biopsies to screen for colon cancer has been performed within the past year
- Subject ≥ 50 years of age who has not had a colonoscopy to screen for colorectal polyps and colon cancer within the past 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VB-201 160mg | Drug | Placebo with crossover to VB-201 160mg, VB-201 160mg |
| Placebo | Drug | Placebo with crossover to VB-201 160mg |
Primary outcome
Modified Mayo Score indicating remission
Time frame: Week 12 and Week 24
The proportion of subjects in remission at Weeks 12 and 24 in the VB-201 160mg (80 mg BID) treatment group compared to placebo group.
1 secondary outcome
Modified Mayo Score indicating response
Time frame: Week 12 and Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VB-201 160mg in people with Ulcerative Colitis, run by Vascular Biogenics Ltd. operating as VBL Therapeutics at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Bulgaria, Hungary, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Mayo Score indicating remission (time frame: Week 12 and Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2015.